The invention relates to a device for storing a liquid medicinal substance, particularly a substance forming a component of a multi-component tissue adhesive. The invention further relates to a method for filling an applicator for a medicinal multi-component substance, particularly for a multi-component tissue adhesive, with the individual components of the medicinal substance and the tissue adhesive, respectively, by use of the above mentioned device.
Known from EP-B-0 037 393, EP-B-0 210 160, U.S. Pat. Nos. 4,874,368, 4,978,336, DE-A-42 23 356, EP-B-0 315 222, WO-A-96/19940 and WO-A-95/31137 are applicators and respectively application devices provided for two-component tissue adhesives and comprising two substantially syringe-body-shaped supply containers attached to the connecting ends of a dispenser device which in turn comprises a dispensing end for dispensing the individual components. The preparation of such an applicator for use e.g. in an operating theater is relatively bothersome and requires a certain routinized skill. For instance, each component of the tissue adhesive has to be introduced in the individual supply containers. The individual components are usually delivered in ampoule-shaped glass vessels having their openings closed by a closure body (septum or the like). By means of a puncture needle mounted to the distal end of the supply container, the closure body is perforated for subsequent suction of its the contents into the supply container. Then, the supply container has to be separated from the puncture needle and connected to the dispenser device. Thus, the preparation of the applicator necessitates a large number of individual steps which are made still more aggravating since the person holding the applicator during filling will have to work under sterile conditions whereas the vessels for the individual components are usually not sterile and thus should not be held by this person. For this reason, these vessels are held by a second person who will position the vessels in such a manner that the person holding the applicator can pierce the puncture needles into the closures bodies for filling the supply containers. In this regard, the risk of injuries to the person holding the vessel should not be underestimated.
The state of the art further includes three-way valves comprising three connectors provided with a switching element for switching the fluid connection. In this case, the switching element is arranged for movement between a first position wherein the first connector is in fluid connection with the second connector and the third connector is shut, and a second position wherein the first connector is in fluid connection with the third connector while the second connector is shut. A three-way valve designed especially for the use of receiving vessels for medicinal substances and having its opening provided with a pierceable closure body is known from WO-A-96/29113.
It has already been proposed to connect the three-way valve known from WO-A-96/29113 between the supply containers and the dispenser device of an applicator for multi-component adhesives. On the one hand, the resultant applicator arrangement is filled in a considerably easier manner because the mechanical connection between the dispenser device and the supply containers is not cut off during the filling process; thus, already before the filling and up to the switching of the three-way valves, the connect or will be in the same condition which it will assume also for applying the tissue adhesive. Still, however, the filling process performed by the above proposed applicator with three-way valve is problematic due to the risk that the person holding the applicator and thus working under sterile conditions might come into contact with the outer surface of the vessel which is not germ-free, i.e. is non-sterile.
It is an object of the invention to provide a device suited to store liquid medicinal substances in such a manner that said substances, in spite of a non-sterile condition of the outer surface of the vessel accommodating the substance, can be handled by a person working under sterile conditions.
To achieve the above object, the invention proposes a device for storing a liquid medicinal substance, particularly a component of a multi-component tissue adhesive, comprising
a vessel for the medicinal substance, said vessel having a bottom wall, a side wall and an opening opposite the bottom wall and closed by a closure body which in turn is pierceable from outside by a puncture needle placed into sealed abutment, and
a receiver cup for said vessel, said receiver cup having a bottom wall and a side wall formed with an edge delimiting the side wall at its upper end opposite the bottom wall.
The device according to the invention serves for taking up a vessel provided to accommodate a liquid medicinal substance and formed with an opening closed by a closure body pierceable by a puncture needle. According to the invention, a vessel of the above type, whose external surface is not germ-free and whichxe2x80x94since its contents would react sensitively to treatment processes for sterilizing its outer surfacexe2x80x94should not be sterilized after filling, can be accommodated in a receiver cup which in turn can be sterilized by the known method. The combination of vessel and receiver cup resulting from the above arrangement can now be handled also by a person working under sterile conditions.
The inventive measure of inserting a vessel with a non-sterile outer surface into a sterilized receiver cup, is suited to facilitatexe2x80x94under the aspect of the safeguarding of a germ-free working processxe2x80x94especially the filling of an applicator for a medicinal multi-component substance and particularly for a multi-component tissue adhesive if the applicator comprises three-way valves adapted to have the vessels coupled thereto and arranged between the supply containers and the dispenser device of the applicator. By means of the inventive device, the filling process will now be performed in that the person working under sterile conditions holds the receiver cup while keeping the opening thereof unobstructed so that another person can introduce the vessel containing the medicinal substance, with the bottom wall thereof facing towards the bottom wall of the receiver cup, into the receiver cup. All of the subsequent processing steps during the filling of the applicator are then carried out by the person working under sterile conditions, with an extremely low danger of this person coming into contact with non-sterilized surfaces of the vessel. Notably, by the same person who also holds the applicator, the vessel arranged in the receiver cup held by that very person can also be mounted onto the coupling adapter of the three-way valve so that, thereafter, the medicinal substance can be sucked from the vessel into the respective supply container by displacing the pistons of the supply containers. By moving the fluid switching element of the three-way valve, the applicator can now be directly used for application, if desired, after removal of the receiver cup holding the vessel therein.
For the handling of the applicator during filling, it is of advantage if the three-way valves comprise the features described in WO-A-96/29113. Thus, particularly, it may be suitably provided that the fluid connection of the three-way valve can be changed by a simple rotating movement of the fluid switch element. Further, it may be suitably provided that the coupling adapter designed to receive the opening region of the vessel is supported for rotation and is connected to the fluid switch element for rotating the latter along with the rotation of the adapter. Further, it is useful for the handling of the applicator during application if the applicator, after the fluid switch element has been moved into its position for establishing a fluid connection between the supply container and the dispenser device of the applicator, can be easily detached.
For the handling of the receiver cup together with the vessel received therein, the hold of the vessel in the receiver cup should be effected in a manner securing the vessel against undesirably falling out of the cup. This can be realized by a retaining means, particularly a retaining means generating friction. By way of alternative, the receiver cup can be formed in such a manner or from such a material that, by application of a force on two sites substantially diametrically opposed to each other, the receiver cup can be elastically deformed, thus obtaining a clamping hold of the vessel in the receiver cup by the force externally applied to the latter.
A device generating friction between the side walls of the vessel an the receiver cup can be realized particularly in that the side wall of the receiver cup is provided with inwardly projecting elastic tongues which preferably are integrally formed to the side wall. Normally, the receiver cup will be made of plastic so that the above spring tongues can be produced by a corresponding configuration of the injection-molding tool provided for the production of the receiver cup. To make it possible that the elastic tongues will have enough freedom for upward movement during insertion of the vessel although the outer diameter of the receiver cup is only slightly larger than that of the vessel, it can be of advantage to provide the side wall of the receiver cup with openings in alignment with the elastic tongues.
Advantageously, each elastic tongue is provided with a first portion connected to the side wall and extending at an inclination thereto, which first portion is joined by a second portion arranged substantially along the extension of the side wall of the receiver cup and preferably ending in the immediate vicinity of the bottom wall. As has been proven in practice, three elastic tongues arranged at a mutual displacement of 120xc2x0 will be sufficient for generating the required friction by which the vessel, e.g. made of glass, is secured in the receiver cup.
Regarding the configuration of the receiver cup provided with said retaining means for securing the vessel in the receiver cup against undesirably sliding out, it is an essential aspect that the receiver cup, in spite of the retaining means, is made from just one material. Exactly this additional requirement is met when the retaining means is realized by the above described elastic tongues, since these elastic tongues are made from the same material as that of the receiver cup and particularly can be generated along with the receiver cup in the same production process (plastic injection-molding technique).
Another receiver cup also includes retaining means for securing therein a vessel containing a liquid medical substance. In this case, the receiver cup includes a side wall and a bottom wall with the retaining means in the form of at least one elastic tongue projecting upwardly into and at least partially along and being at least partially spaced from an inner surface of the receiver cup side wall. Such one or more elastic tongues each have a free end spaced from the receiver cup bottom wall, and each elastic tongue frictionally engages an exterior surface of the vessel containing the liquid medical substance.
An embodiment of the invention and particularly the process for filling an applicator for medicinal substances will be explained in greater detail hereunder with reference to the Figures. In the Figures: